Microsoft Word - Draft OMB Meeting Agenda-April 11 2019

OMB Meeting 4-11-2019 Pre-read Materials

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OMAMAN-31 E: AOAC RI PTM Report 091501 ERP Use Only - March 2016

A Comparative Evaluation of the 3M ™ Molecular Detection Assay 2 – Salmonella for the Detection of Salmonella in a Variety of Foods and Environmental Surfaces

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AOAC Performance Tested Methods SM 091501

Abstract

The 3M ™ Molecular Detection Assay 2 (MDA2) - Salmonella employs Real-Time Isothermal technology for the rapid and accurate detection of Salmonella species from select food matrixes and environmental surfaces. The 3M MDA 2 - Salmonella was evaluated according to the current AOAC microbiology guidelines. The validation consisted of an inclusivity/exclusivity study, a method comparison study of 15 food matrixes and 3 environmental surfaces, a stability (lot-to-lot) study, and a robustness study. Of the 111 Salmonella serotypes evaluated in the inclusivity study, 109 were detected at both 37°C and 41.5°C. Two additional strains of those undetected, Salmonella Urbana and Salmonella Poona, were evaluated at both temperatures and were detected. None of the 30 non- Salmonella strains were detected by the 3M MDA 2 – Salmonella method. The 3MMDA 2 - Salmonella was compared to the following methods: 1. USDA/FSIS-MLG 4.08 Isolation and Identification of Salmonella from Meat, Poultry, Pasteurized Egg and Catfish Products and Carcass and Environmental Sponges (2014) for raw ground beef (73% lean), raw ground chicken, chicken carcass rinse, chicken carcass sponge, pasteurized liquid whole egg, and cooked breaded chicken. 2. FDA/BAM Chapter 5 Salmonella (2014) for instant non-fat dry milk, black pepper, cocoa powder, raw whole shrimp, raw bagged spinach, creamy peanut butter, dry dog food, pasteurized-processed American cheese, sealed concrete, stainless steel, sealed ceramic tile. 3. FDA Guidance for Industry: Sampling and Microbial Testing of Spent Irrigation Water during Sprout Production for spent sprout irrigation water. In the method comparison study, the 3M MDA 2 - Salmonella demonstrated no significant specified enrichment times. For the stability (lot-to-lot) study, the results of the evaluation indicated no discrepant results among the three lots of test kits at the beginning, middle, and end of their shelf-life. For the robustness study, changing the operational parameters of the lysis heat time, DNA sample volume, or the lysis solution volume, had no statistically significant effect on the results for all 8 different variations. The results of this evaluation demonstrate the specificity and sensitivity of the 3M MDA 2 - Salmonella and its ability to accurately detect Salmonella in AOAC Research Institute Expert Review Panel Use Only differences between presumptive and confirmed results (dPOD CP ) or between candidate and reference method results (dPOD C ) for all 15 food matrixes and 3 environmental surfaces after select food matrixes and environmental surfaces. Authors Lisa Monteroso and DeAnn Benesh, 3M Food Safety Division Ben Bastin, Erin Crowley, Patrick Bird, M. Joseph Benzinger, Jr., James Agin, and David Goins,

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Q Laboratories, Inc.

Submitting Company

3M Company

Food Safety Department 3M Center, Bldg. 275-5W-05 St. Paul, MN 55144-1000

04/05/2019